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Pharma-Academic Alliances: What the Numbers Don’t Tell You

a foundation of basic studies whose value when the discoveries were made wasn’t always understood. Who at the time would have ascribed any practical utility to Oswald Avery’s investigations that revealed that DNA was the genetic material? Think about some of the most important basic science discoveries over the past century. What would have happened if Watson and Crick had their attention diverted away from solving the structure of the double helix to work on a pharma problem brought to the Cavendish Laboratory at Cambridge by Glaxo?

I’m not saying that these pharma-academic department alliances are necessarily a bad thing. However, these deals raise a number of questions about the degree of control the companies have over the research and, more specifically, over the investigators themselves. Here is a brief list of some of the issues that I haven’t seen discussed, but which are likely to concern the academic investigators involved:

—Who decides on how the money gets spent?

—Who has the authority to determine which investigators within a department or organization get some of the pharma money, and which ones don’t?

—Will the company play a role in specifying which projects an investigator works on?

—Can the pharma partner specifically block investigators from collaborating with other academic investigators or another (possibly competing) drug company?

—Will work done by an investigator within the alliance affect their ability to get tenure?

—Does the pharma partner get to review (and approve) publications and presentations by the researchers before they are submitted?

—Will the filing of patents result in any delays in reporting the work?

One other important matter that must be clarified at the outset of these alliances involves identifying the source of funding of specific projects. For example, if a researcher within one of these academic departments is working on a grant funded by the NIH, then the Bayh-Dole Act would likely cover any inventions that might emerge from their lab. Congress created this Act in 1980 in order to facilitate the commercialization of academic discoveries from the nation’s research labs. One could easily envision a situation where an investigator’s NIH grant money gets switched to funding supplied by the pharmaceutical company. Patents and commercial products that derived from this work might then belong solely to the pharma company, with the university unable to make a claim for a share of the profits. This might be an acceptable trade off for either the university or the academic department in exchange for the funds that the pharma partner is providing. Alliance agreements with academia are almost certainly constructed to favor the pharmaceutical firms if a moneymaking idea or product springs forth from the work. However, without knowing exactly how these alliances are structured, it is impossible to determine just what, if anything, the academic side is giving up.

Will these alliances be successful in re-energizing Big Pharma? It’s simply too early to tell, and the missing details make these arrangements difficult to judge from several different perspectives. What I can tell you is that these alliances need to be carefully managed. I teach scientists and pharma/biotech companies how to facilitate successful collaborations and alliances, and I’ve witnessed numerous problems that can arise from these arrangements. Ignoring your partner’s concerns, or failing to act on them in a timely manner, is a recipe for failure. Once your collaboration or alliance derails, it is extremely difficult to get it back on track and moving forward. The correct mindset probably involves thinking of these associations as being akin to a marriage. Each is filled with give and take, with negotiations, with misunderstandings, and even occasionally bad intentions. Whether they will be productive in the long term depends on the commitment of the participants to work through the various problems that will inevitably crop up.

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The Author

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides strategic advice to clients on their research programs, collaboration management issues, as well as preclinical data reviews.

For myself, the main question is how do these arrangements with public, non-profit institutions (Universities) remain private? Isn’t there a mechanism for those documents to be released to the public (who paid for them)?

http://qb3.org regis kelly

Stewart Lyman makes a profession out of consulting with academia and industries about alliance formation. Nonetheless he seems to be deeply concerned that “Big Pharma has gone alliance crazy”. It is hard to know why he is so incensed. Everyone, including Lyman, knows that Big Pharma is looking around for new models and knows why. His main concern seems to be the classic one for angry letter writers – “If I do not know the details then I will assume that bad things are being done” I have been involved in several of the UCSF deals mentioned by Lyman. As an academic researcher completely committed to improving human health, I can assure Lyman that these deals were made because we believed that we could advance human health better by making them than by staying in our ivory towers. Academics like myself are great at discovery but are frequently embarrassingly ignorant of the useful applications of our discoveries. Alliances with Pharma can bring the knowledge of society needs that we lack. It may be hard for Lyman to believe but it was NOT about the money. While no doubt lacking Lyman’s years of experience in negotiating alliance deals, we are not fools and we get very good advice in making such deals from many local experts who provide pro bono help. In addition the University of California has very strong guidelines to make sure that any agreement made with a company does not damage our educational mission or imperil our reputation for objectivity. If he wanted his seven questions answered, why didn’t he just call? The answers are not secret. Finally the old concern about NIH funding being misused for commercial purposes should be allayed by reading bullet point three of NIH’s mission statement. Surprisingly few have.

http://www.lymanbiopharma.com Stewart Lyman

It is indeed a pleasure to have Regis Kelly, director of the California Institute for Quantitative Biological Research (QB3) respond to my article. I don’t personally know him, or I might have called him (had I known he was the person to ask) to have the questions I posed in my article answered. I appreciate his commitment to translational research and hope that the mission of his organization is successful. While he accuses me of being an “angry letter writer” for asking what I (and others) thought were some pertinent questions, his response failed to answer the questions raised. I invite him to post his answers to the seven questions that I put forth to educate both myself and Xconomy readers on how these agreements come together. That way, researchers throughout the country will understand how your deal was structured and have a basis for comparison to the one’s that their own institutions may have entered into or are considering. And if the deal was not about the money, as you indicate, I would be happy to provide you with some suggestions for organizations that could put in to good use. You can even keep the money local and focused on translational research. Perhaps the Institute for One World Health in SF would welcome some additional funding?

While you take me to task for raising these questions, others I have heard from have offered different opinions and tell me that they have spent considerable time discussing the very issues that I brought up for discussion. And I’m not sure why you accuse me of being “incensed” just because I have the temerity to ask some questions about these deals. As we know, the devil is in the details, and UCSF, where Regis works, is associated with one of the saddest past chapters of pharma-academic dealings, the Boots Synthroid affair. This story has been well documented and I direct readers to the original story published in the Wall Street Journal in 1996 “How a drug firm paid for a university study, then undermined it”, or any of the review articles that covered this case (see Science 273, p 411, 1996 for an editorial reviewing the matter). Essentially, a UCSF researcher was hired to do a basic research project for the Boots Pharmaceutical company. When the company did not like the published results, it forced the authors to retract an article describing their work and, according to the Science article, “brought the university to its knees with threats of a protracted lawsuit”. One of the key points was that the researcher had ignored a clause in a 21-page research contract that required the company to review any papers before they were published. UCSF policy at the time would not have allowed the contract to be signed, but the researcher signed it anyway. Derek Bok, former President of Harvard, is quoted in the Science piece as saying “the price of corporate support is eternal vigilance.” No doubt that many universities and research institutions, including UCSF, revised and tightened their protocols for entering into these types of agreements after this affair became known. Pharma and biotech organizations used to make do with the signature of just the researcher that they wanted to work with, but a sign-off by university officials is now standard protocol in material transfer agreements.

It certainly makes sense for pharma and biotech to work with academic researchers to improve the drug discovery and development process. When I worked in biotech, I personally set up well over one hundred collaborations with academics to facilitate our getting a clear understanding of the biology of the proteins encoded by the novel genes I had cloned. Amazingly enough, the vast majority (>99%) of these deals were done without providing the investigators with a single dime of support (they were simply supplied with the new protein or a cDNA for their experiments).

Let’s see if we can get other academic researchers to weigh in with their thoughts about these agreements. Are there any concerns? Have their been any problems? Is this all really a non-issue?

http://qb3.org regis kelly

After I claimed that there were no secret dealings involved in the alliances I have knowledge of, I was challenged to provide the answers to the seven questions that were raised. To be as accurate as possible I will base my answers on the collaboration that QB3 has with Pfizer and which I know the best. 1. Who decides? A steering committee of UCSF and Pfizer scientists choose from submitted non-confidential applications. 2. Who authorizes? The steering committee decides. 3. Choice of projects? The steering committee chooses from submitted applications and does not specify the science in the projects. 4. Exclusivity? A pharma company would not be comfortable working with an academic partner who is exploring the same target for another pharma company. 5. Tenure? A sponsored research agreement with Pfizer brings in indirect costs at the same level as NIH funding. To the extent that tenure is given on the basis of the ability to attract funding of any sort, an industry sponsored research agreement could contribute positively towards tenure. I do not know if we have any statistics on the influence of sponsored resaerch agreements on the tenure process, negative or positive. 6. Review of papers? Sponsors do have the right to review manuscripts describing the research they have funded several weeks in advance of publication. Usually this is done while the manuscript is still in an early stage of composition in order not to slow down the publication process. 7. Intellectual property based on research in university labs supported by industry still belongs to the University of California. Out technology transfer agents will encourage disclosure and patent filing on potentially commercializable research, which can slow down the publication process. Thus, filing of patents can indeed result in a slow down in publication of results, but this is true whther it is funded by industry or the NIH. I am not aware of any difference that depends on funding source. I hope this helps you and other readers of Xconomy understand the process a little more clearly. I wonder if some of the confusion may come from the assumption that an “$85 milion award”, for example, comes with a check for that amount of money? It is more a reasonable estimate of what both parties think will be spent on research projects of mutual interest over the time period of the agreement.

Robert Jones

None of our local scholars see a problem with what has been laid out here? Sponsors have the right to review manuscripts? Are they checking for spelling errors? There are numerous examples of corporate sponsors dictating the conclusions of a researchers work.

Regis, thank you for providing this information, which is very helpful to those of us seeking to have a better understanding of the process. I have just a few follow-on questions:

1) What percentage of the steering committee members are from UCSF, and what percentage from Pfizer?

2) I understand that Pfizer would not want scientists to work on the same target with another company, which is perfectly sensible. Can a researcher working on target A with Pfizer work on a separate target B with Merck?

3) I am sure that many of your researchers would want to tap into the financial resources being offered. If only a few researchers, however, wanted to participate, or alternatively, the steering committee only thought a few proposals were worthy of support, then I presume the total amount of money spent here would drop significantly?

4) Finally, assuming that the highest amount of money available was actually spent, can you estimate what percentage of the total research budget of QB3 would be coming (a) from Pfizer, and (b) from all industry supported activities?